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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vaginoscope and accessories
510(k) Number K950639
Device Name KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact RENATE A MACLAREN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact RENATE A MACLAREN
Regulation Number884.1630
Classification Product Code
MOK  
Date Received02/13/1995
Decision Date 06/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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